Restless Legs SyndromePhase 3NCT00625547
A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
A Phase 3 study testing cabergoline and levodopa in people with Restless Legs Syndrome, run by Pfizer at 50 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- cabergoline and levodopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 50 sitesin 4 countries
- Study dates
- Jan 2003to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
- Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
- No previous treatment for RLS or dissatisfaction with their current therapy
Who cannot join
- Not available
Trial locations and contacts
50 sites in 4 countries.
50 sites in 4 countries
Germany42 sites
Pfizer Investigational Site
Altötting, 84503
Pfizer Investigational Site
Aschaffenburg, 63739
Pfizer Investigational Site
Bad Honnef, 53604
Pfizer Investigational Site
Bad Saarow, 15526
Pfizer Investigational Site
Beckum, 49269
Pfizer Investigational Site
Berlin, 10969
Pfizer Investigational Site
Berlin, 12163
Pfizer Investigational Site
Berlin, 12687
Pfizer Investigational Site
Berlin, 13053
Pfizer Investigational Site
Berlin, 13507
Pfizer Investigational Site
Bochum
Pfizer Investigational Site
Bremerhaven, 27568
Pfizer Investigational Site
Dillingen, 66763
Pfizer Investigational Site
Duisburg
Pfizer Investigational Site
Düsseldorf, 40211
Pfizer Investigational Site
Gelsenkirchen, 45891
Pfizer Investigational Site
Gera, 0755
Pfizer Investigational Site
Göttingen, 37037
Pfizer Investigational Site
Göttingen, 37075
Pfizer Investigational Site
Halle, 06118
Pfizer Investigational Site
Hamburg, 22359
Pfizer Investigational Site
Heilbronn, 74072
Pfizer Investigational Site
Jena
Pfizer Investigational Site
Kaiserslautern, 67655
Pfizer Investigational Site
Karlsruhe, 76137
Pfizer Investigational Site
Karlsruhe
Pfizer Investigational Site
Kassel, 34128
Pfizer Investigational Site
Köthen
Pfizer Investigational Site
Marburg, 35039
Pfizer Investigational Site
Mittweida, 09648
Pfizer Investigational Site
Mönchengladbach, 41179
Pfizer Investigational Site
Neubrandenburg, 17033
Pfizer Investigational Site
Oldenburg, 26122
Pfizer Investigational Site
Quickborn, 25451
Pfizer Investigational Site
Regensburg, 93053
Pfizer Investigational Site
Schwalmstadt, 34613
Pfizer Investigational Site
Schwerin, 19055
Pfizer Investigational Site
Stuttgart, 70176
Pfizer Investigational Site
Tuttlingen, 78532
Pfizer Investigational Site
Ulm, 89073
Pfizer Investigational Site
Wiesbaden, 65191
Pfizer Investigational Site
Wolfsburg
Sweden3 sites
Pfizer Investigational Site
Gothenburg, S-413 45
Pfizer Investigational Site
Karlstad
Pfizer Investigational Site
Linköping, 581 85
Switzerland3 sites
Pfizer Investigational Site
Basel, Basel, 4031
Pfizer Investigational Site
Bern, Canton of Bern
Pfizer Investigational Site
Zurich, CH-8091
Austria2 sites
Pfizer Investigational Site
Innsbruck, 6020
Pfizer Investigational Site
Vienna, A-1090
About this study
Official title: A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
- Conditions
- Restless Legs Syndrome
- Being tested
- cabergoline, levodopa
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabergolineDrug
Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events
levodopaDrug
Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: cabergoline |
| 2 | Experimental | Not described Receives: Drug: levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)
Measured: Week 6
Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)
Secondary outcomes (10)
RLS quality-of-life questionnaire
Measured: Weeks 6 and 30
Clinical Global Impression
Measured: Weeks 6 and 30
Patient Global Impression
Measured: Weeks 6 and 30
Sleep questionnaire form A
Measured: Weeks 6 and 30
IRLSSG-RS
Measured: Week 30
Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram
Measured: Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2
Rating of severity of RLS at night (RLS-6 scale)
Measured: Weeks 6 and 30
Rating of severity of RLS before bedtime (RLS-6 scale)
Measured: Weeks 6 and 30
Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)
Measured: Weeks 6 and 30
Global rating of quality of sleep (RLS-6 scale)
Measured: Weeks 6 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJan 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625547
- Sponsor's protocol ID
- CABAS-0067-031
- Status last verified
- Oct 2008
- First submitted
- 19 Feb 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT00625547
- Acronym / sponsor ID
- CABAS-0067-031
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Dec 2004 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cabergoline |
| 2 | Experimental | Drug: levodopa |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
- Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
- No previous treatment for RLS or dissatisfaction with their current therapy
Key exclusion criteria (1 listed)
- Not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cabergolineCabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events | Drug | 1 |
| levodopaLevodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events | Drug | 2 |
Primary outcome
Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)
Time frame: Week 6
Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)
10 secondary outcomes
RLS quality-of-life questionnaire
Time frame: Weeks 6 and 30
Clinical Global Impression
Time frame: Weeks 6 and 30
Patient Global Impression
Time frame: Weeks 6 and 30
Sleep questionnaire form A
Time frame: Weeks 6 and 30
IRLSSG-RS
Time frame: Week 30
Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram
Time frame: Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2
Rating of severity of RLS at night (RLS-6 scale)
Time frame: Weeks 6 and 30
Rating of severity of RLS before bedtime (RLS-6 scale)
Time frame: Weeks 6 and 30
Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)
Time frame: Weeks 6 and 30
Global rating of quality of sleep (RLS-6 scale)
Time frame: Weeks 6 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
50 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cabergoline and levodopa in people with Restless Legs Syndrome, run by Pfizer at 50 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Germany, Sweden, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS) (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2008.